Method for treatment and disposal of pharmaceutical waste

ABSTRACT

An exemplary system for treatment and disposal of pharmaceutical waste comprises a sealable pail, a stirring device, a sealable bag, a container, an acidic substance, and a denaturant. The sealable pail receives the pharmaceutical waste and the acidic substance. The acidic substance dissolves the pharmaceutical waste, and the stirring device stirs the acidic substance to ensure that the pharmaceutical waste is completely dissolved. The denaturant is added to the dissolved pharmaceutical waste and renders the dissolved pharmaceutical waste safe for transport. The treated pharmaceutical waste is sealed within the sealable pail, and the sealable bag receives the sealed pail and is sealed. The sealed bag is then placed in the container for transport to a disposal facility.

CROSS REFERENCE TO RELATED APPLICATION

This application claims priority to U.S. provisional patent applicationno. 61/497,609, entitled “System and Method for Treatment and Disposalof Pharmaceutical Waste” and filed on Jun. 16, 2011, which isincorporated herein by reference.

RELATED ART

The disposal of pharmaceutical waste, particularly controlledsubstances, is problematic due to the numerous laws and regulationsgoverning such disposal. Various federal agencies such as, for example,the Drug Enforcement Administration (DEA), the Department of Justice(DOJ), the Environmental Protection Agency (EPA), and the Department ofTransportation, among others, regulate the acquisition, transportationand disposal of pharmaceutical waste. Such regulation is necessary dueto the fact that pharmaceutical waste is often classified as acontrolled substance. Thus, the numerous federal laws aimed at punishingtrafficking of controlled substances, which often carry severe fines andpenalties, may be applied to individuals attempting to dispose ofpharmaceutical waste.

In order to avoid violating such laws, individuals and companies oftendispose of the pharmaceutical waste improperly, such as, for example, bymerely flushing it down a toilet or throwing it in the trash. However,such improper disposal of pharmaceutical waste can result incontamination of lakes, rivers and water supplies which can endanger thehealth of people, wildlife and the environment. Accordingly, systems andmethods for treating and disposing of pharmaceutical waste are desired.

BRIEF DESCRIPTION OF THE DRAWINGS

The present disclosure can be better understood with reference to thefollowing drawings. The elements of the drawings are not necessarily toscale relative to each other, emphasis instead being placed upon clearlyillustrating the principles of the disclosure. Furthermore, likereference numerals designate corresponding parts throughout the severalviews.

FIG. 1 is a perspective view of a pharmaceutical waste treatment anddisposal system according to an exemplary embodiment of the presentdisclosure.

FIG. 2 is a perspective view of the pharmaceutical waste treatment anddisposal system of FIG. 1 with treated pharmaceutical waste sealedwithin the pail.

FIG. 3 is a perspective view of the pharmaceutical waste treatment anddisposal system of FIG. 1 with the sealed pail positioned within thesealed bag and the container.

FIG. 4 is a flowchart depicting an exemplary method for treatment anddisposal of pharmaceutical waste.

DETAILED DESCRIPTION

Embodiments of the present disclosure generally pertain to systems andmethods for treatment and disposal of pharmaceutical waste. A method fortreatment and disposal of pharmaceutical waste according to an exemplaryembodiment of the present disclosure comprises the steps of placingpharmaceutical waste in a sealable pail, treating the pharmaceuticalwaste with an acidic liquid substance, stirring the acidic liquidsubstance and the pharmaceutical waste with a stirring device, treatingthe dissolved pharmaceutical waste with a denaturant, sealing thetreated pharmaceutical waste within the sealable pail, sealing thesealed pail within a sealable bag, placing the sealed bag in acontainer, and transporting the container to a disposal facility.

A system for treatment and disposal of pharmaceutical waste according toan exemplary embodiment of the present disclosure comprises a sealablepail, a stirring device, a sealable bag, a container, an acidicsubstance, and a denaturant. The sealable pail receives thepharmaceutical waste and the acidic substance. The acidic substancedissolves the pharmaceutical waste, and the stirring device stirs theacidic substance to ensure that the pharmaceutical waste is completelydissolved. The denaturant is added to the dissolved pharmaceutical wasteand renders the dissolved pharmaceutical waste safe for transport. Thetreated pharmaceutical waste is sealed within the sealable pail, and thesealable bag receives the sealed pail and is sealed. The sealed bag isthen placed in the container for transport to a disposal facility.

FIG. 1 is a front perspective view of an exemplary pharmaceutical wastetreatment and disposal system 10. In one embodiment, the system 10comprises a sealable pail 12, a stirring device 15, a sealable bag 17, acontainer 20, an acidic substance 22, and a denaturant 25. The sealablepail 12 has a lid 27 for sealing the pail 12 in order to preventcontents of the pail 12 from spilling or leaking. In one embodiment, thelid 27 forms a twist-on seal (not shown) with the pail 12, althoughother types of seals are possible in other embodiments. The sealablepail 12 and the lid 27 comprise rigid material suitable for withstandingcontact with the acidic substance 22 and the denaturant 25. In oneembodiment, the sealable pail 12 and the lid 27 comprise non-reactiveplastic, although other materials, such as, for example, glass, arepossible in other embodiments. In one embodiment, the lid 27 comprises aself-locking device in order to ensure that no contents will leak fromthe pail 12 when the lid 27 is secured on the pail 12. Furthermore, thelid 27 may comprise a tamper evident system (not shown) for verifyingthat the contents of the pail 12 are not disturbed during transport. Thepail 12 may come in one-gallon size and five-gallon size, although othersizes are possible within the scope of the present disclosure.

The sealable pail 12 receives pharmaceutical waste (not shown), such as,for example, prescription pills, capsules, and/or liquids. The sealablepail 12 also receives the acidic substance 22. The acidic substance 22comprises a chemical formulation designed to dissolve the pharmaceuticalwaste while maintaining a pH level that is tolerable to human touch,such as, for example, a pH level in the range of approximately 4.0-4.5.In one embodiment, the acidic substance 22 comprises a mineral acid,such as, for example, orthophosphoric acid, although other acidicsubstances 22 are possible in other embodiments. For example, the acidicsubstance 22 may comprise hydrochloric acid, acetic acid, nitric acid,sulfuric acid, polyphosphoric acid, boric acid, hydrofluoric acid,hydrobromic acid, or perchloric acid in other embodiments. In oneembodiment, the acidic substance 22 comprises liquid, although thesubstance 22 may comprise a solid in other embodiments. Note that theacidic substance 22 mimics human gastric acidity in order to dissolvethe substances comprising the pharmaceutical waste. Thus, in oneembodiment, the acidic substance 22 converts at least a portion aportion of the solid pharmaceutical waste, such as, for example, aprescription pill or capsule, into liquid form.

A predetermined amount of the acidic substance 22 should be added to thepharmaceutical waste in order to properly dissolve the waste. Suchamount may be dependent on the volume of waste which must be dissolved.For example, in one embodiment, the acidic substance 22 may comprise onepart concentrate and nine parts water. Two parts of such acidicsubstance 22 are then added for every one part of the pharmaceuticalwaste in the pail 12 in order to fully dissolve the pharmaceuticalwaste. However, other ratios of concentrate to water and acidicsubstance 22 to pharmaceutical waste are possible in other embodiments.

The sealable pail 12 also receives the denaturant 25. The denaturant 25comprises a chemical formulation designed to denature the pharmaceuticalwaste thereby rendering it inert. In one embodiment, the denaturant 25comprises a quaternary ammonium cation, such as, for example, denatoniumbenzoate, although other types of denaturants 25 are possible in otherembodiments. For example, the denaturant 25 may comprise denatoniumsaccharide, isopropanol, methyl ethyl ketone, methyl isobutyl ketone,pyridine, benzene, diethyl phthalate, or naptha in other embodiments.The type of denaturant 25 used may vary depending on the type ofpharmaceutical waste being denatured. After the acidic substance 22completely dissolves the pharmaceutical waste, the denaturant 25 isapplied to the dissolved pharmaceutical waste in order to denature thepharmaceutical waste and render the waste safe for transport. In thisregard, transporting controlled substances is regulated by federal law,and the denaturant is configured to convert the pharmaceutical wasteinto a form which is no longer harmful and is no longer classified as acontrolled substance such that the treated pharmaceutical waste issafely transported and disposed of in compliance with federal law. Inone embodiment, the denaturant 25 is supplied in vials (not shown)having a one-ounce size and a five-ounce size. Thus, the one-ounce sizevial of denaturant 25 is used with the one-gallon pail 12 ofpharmaceutical waste, and the five-ounce size vial of denaturant 25 isused with the five-gallon pail 12 of pharmaceutical waste. However, thedenaturant 25 may come in other sizes and containers in otherembodiments.

The stirring device 15 is configured to stir the contents of the pail 12in order to treat the pharmaceutical waste. For example, the stirringdevice 15 stirs the acidic substance 22 with the pharmaceutical wastewhile the substance 22 and the waste are in the pail 12 in order to mixthe substance 22 with the waste and completely dissolve the waste. Inone embodiment, the stirring device 15 comprises a manual stirringdevice, such as, for example, a large plastic stirrer. However, in otherembodiments, the stirring device 15 may comprise an automatic stirringdevice having a motor. Other materials, such as, for example, metal, mayalso be used for the stirring device 15. The stirring device 15 shortensthe time required to dissolve the pharmaceutical waste within the acidicsubstance 22 by exposing unexposed portions of the waste to thesubstance 22. Furthermore, the stirring device 15 may be used to mix thedenaturant 25 with the dissolved pharmaceutical waste. In this regard,the denaturant 25 is added to the dissolved pharmaceutical waste withinthe pail 12 once the waste is completely dissolved within the acidicsubstance 22 and has been left to sit for a predetermined amount oftime. In one embodiment, a time period of 6 hours is suggested in orderto completely dissolve the pharmaceutical waste within the acidicsubstance 22, although other time periods are possible. For example, alonger time period may be required for soaking time-releasedprescription pills and/or capsules in the acidic substance 22. Once thedenaturant 25 is added to the dissolved pharmaceutical waste, thestirring device 15 may be used to mix the denaturant 25 with thedissolved pharmaceutical waste in order to completely mix the two andensure that the pharmaceutical waste is denatured and rendered inertthereby rendering it safe for transport. Any particulate which remainsafter stirring is completed should be removed from the pail 12, crushed,and treated by the acidic substance 22 in a later batch ofpharmaceutical waste.

Once the pharmaceutical waste is sufficiently treated and rendered safefor transport, the lid 27 is secured on the pail 12 in order to create awater-tight seal. The sealable bag 17 receives and encloses the sealedpail 12 containing the treated pharmaceutical waste. The sealable bag 17may comprise plastic or other leak-resistant material in order toprevent any substance which may leak from the pail 12 from leaking fromthe bag 17. The sealable bag 17 may be sealed with any suitable meansfor creating a water-tight seal, such as, for example, a clamp, a twisttie, a zip tie or by tying an end of the bag 17. Other means for sealingthe bag 17 are possible in other embodiments. While a bag 17 isdescribed herein, any other suitable containment means capable of beingsealed are possible in other embodiments. The sealable bag 17 functionsas a secondary seal in order to trap any treated pharmaceutical wastewhich may inadvertently spill or leak from the pail 12. Accordingly, thetreated pharmaceutical waste may be transported safely without fear ofcontamination resulting from spills or leaks.

The container 20 receives the sealed bag 17 containing the sealed pail12 which contains the treated pharmaceutical waste. The container 20comprises a material suitable for being shipped and/or transported. Inone embodiment, the container 20 comprises a cardboard box. However, thecontainer 20 may comprise other materials, such as, for example,plastic, in other embodiments. Furthermore, the container 20 may havesupports (not shown), such as, for example, cardboard or Styrofoamsupports, located within the container 20 in order to keep the sealedpail 12 secured within the container 20 during transport. The container20 may also have at least one pouch 30 located on an outer surface ofthe container 20 for attaching necessary papers. For example, suchpapers may indicate the specific contents of the container 20, such asthe type of pharmaceutical waste being transported. Furthermore, thecontainer 20 may also have an identifier 32, such as, for example, abarcode, located on an outer surface of the container 20 for trackingthe location of the container 20 and verifying disposal/destruction ofthe pharmaceutical waste in order to ensure compliance with federallaws. Other necessary information may be located on the container 20 inother embodiments.

FIG. 2 is a perspective view of the pharmaceutical waste treatment anddisposal system of FIG. 1 with treated pharmaceutical waste 35 sealedwithin the pail 12. After the pharmaceutical waste 35 has been properlytreated with the acidic substance 22 (FIG. 1) and the denaturant 25(FIG. 1), the lid 27 is secured onto the pail 12 in order to seal thetreated pharmaceutical waste 35 within the pail 12. The sealed pail 12is inserted into an opening 37 of the sealable bag 17. The bag 17 isdimensioned such that the sealed pail 12 will fit completely within thebag 17 with enough room for the opening 37 to be sealed shut therebysealing the pail 12 within the bag 17. As set forth above, the bag 17may be sealed by any suitable sealing means. Sealing the sealed pail 12within the bag 17 provides two leak-resistant layers which contain thetreated pharmaceutical waste 35 within the bag 17 in order to preventcontamination of the container 20 or the environment.

The sealed bag 17 containing the sealed pail 12 with the treatedpharmaceutical waste 35 is inserted into an opening 40 of the container20. The container 20 is dimensioned such that the bag 17 containing thesealed pail 12 fits within the opening 40. As set forth above, thecontainer 20 may also have supports (not shown) positioned within theopening 40 in order to stabilize the pail 12 within the container 20during transport. Once the bag 17 is positioned within the opening 40 ofthe container 20, the container 20 is shipped and/or transported to thedisposal facility (not shown). The treated pharmaceutical waste 35 isrendered safe for transport by the acidic substance 22 and thedenaturant 25, and the sealed pail 12 and the sealed bag 17 ensure thatthe pharmaceutical waste does not spill and contaminate the environment.Accordingly, the pharmaceutical waste treatment and disposal system 10is provided.

FIG. 3 is a perspective view of the pharmaceutical waste treatment anddisposal system 10 of FIG. 1 with the sealed pail 12 positioned withinthe sealed bag 17 and the container 20. As shown by FIG. 3, the treatedpharmaceutical waste 35 is sealed within the pail 12 by the lid 27.Furthermore, the sealed bag 17 traps any treated pharmaceutical waste 35which may spill or leak from the pail 12. An end of the bag 17 depictedin FIG. 3 is tied shut forming a water-tight, leak-resistant seal.However, as set forth above, other means for sealing the bag 17 arepossible in other embodiments.

When the bag 17 containing the pail 12 is positioned within thecontainer 20, the container 20 may be shipped or otherwise transportedto a disposal facility. Note that the container 20 may be shipped safelywhile complying with all applicable laws. Furthermore, as set forthabove, supports (not shown) may be used to stabilize the pail 12 withinthe container 20 when the container 20 is shipped in order to preventthe pail 12 from shifting during transport. The container 20 containingthe treated pharmaceutical waste 35 is sent to the disposal facility tobe destroyed. Accordingly, contamination of lakes, rivers and watersupplies by pharmaceutical waste 35 is avoided.

In one exemplary embodiment, assume that the acidic substance 22comprises one part orthophosphoric acid concentrate and nine partswater. Also assume that the denaturant 25 comprises denatonium benzoate.Furthermore, assume that a one-gallon pail 12 is used and thepharmaceutical waste 35 comprises prescription pills. Finally, assumethe container 20 comprises a cardboard box suitable for shipping.

A user places the pharmaceutical waste 35 in the sealable pail 12, asshown by block 100 of FIG. 4. In the present embodiment, such stepinvolves placing a desired number of the prescription pills in the pail12. However, the number of prescription pills should be limited suchthat a proper amount of the acidic substance 22 may be added withoutoverflowing the pail 12. Once the pharmaceutical waste 35 is positionedwithin the pail 12, the acidic substance 22 is then added to thepharmaceutical waste 35, as shown by block 102. In this regard, twoparts of the acidic substance 22 are added for every one part of thepharmaceutical waste 35. Such ratio allows enough of the acidicsubstance 22 to completely dissolve the pharmaceutical waste 35.

After the acidic substance 22 has been added to the pharmaceutical waste35, the acidic substance 22 and the pharmaceutical waste 35 are stirredwith the stirring device 15, as shown by block 104. The pharmaceuticalwaste 35 must be completely dissolved in order to be rendered safe fortransport. Thus, stirring the substance 22 and the waste 35 with thestirring device 15 helps to speed up the process of dissolving the waste35 by exposing unexposed portions of the waste 35 to the substance 22.After stirring is complete, the pharmaceutical waste 35 may be requiredto soak in the acidic substance 22 for a specified period of time inorder to allow the waste 35 to dissolve completely within the substance22. In one embodiment, the waste 35 is required to soak in the acidicsubstance 22 for 6-12 hours, although other time periods are possible.Completely dissolving the pharmaceutical waste 35 in the acidicsubstance 22 prepares the waste 35 for treatment with the denaturant 25.

Once the pharmaceutical waste 35 is completely dissolved in the acidicsubstance 22, the pharmaceutical waste 35 is treated with the denaturant25, as shown by block 106. In this regard, since the pail 12 is aone-gallon pail 12, a one-ounce sized vial of the denaturant 25 is addedto the pail 12 in order to treat and denature the pharmaceutical waste35. The stirring device 15 is again used in order to stir the denaturant15 with the dissolved pharmaceutical waste 35 and acidic substance 22and to expose the dissolved waste 35 to the denaturant 25. Such exposureto the denaturant 25 renders the pharmaceutical waste 35 safe fortransport since the waste 35 has now been properly treated. Note thatthe treated pharmaceutical waste 35 may be required to sit for aspecified period of time prior to sealing the pail 12 shut in order toensure that the pharmaceutical waste 35 is sufficiently treated andrendered inert.

Upon sufficiently treating the pharmaceutical waste 35 with thedenaturant 25, the treated pharmaceutical waste 35 is sealed within thesealable pail 12, as shown by block 108. In this regard, the lid 27 issecured on the pail 12 such that a water-tight seal is formed around anopening of the pail 12 thereby preventing the treated pharmaceuticalwaste 35 from escaping the pail 12. The lid 27 may have a self-lockingdevice in order to ensure the lid 27 is secured to the pail 12, and thelid 27 may also have a tamper-evident seal in order to prevent tamperingwith the treated pharmaceutical waste 35. The sealed pail 12 is thensealed within the sealable bag 17, as shown by block 110. In oneembodiment, an end of the sealed bag 17 is tied in a knot in order toclose the opening 37 of the bag 17 and to create a water-tight seal.However, as set forth above, other means for sealing the bag 17 arepossible in other embodiments.

Once the bag 17 is sealed, the bag 17 is placed in the container 20 forshipping, as shown by block 112. The pail 12 may be supported within thecontainer 20 in order to stabilize the pail 12 during transport and todecrease the likelihood of spills or leaks from the pail 12. After thepail 12 and bag 17 are in a desirable position within the container 20,the container is closed and prepared for shipping and/or transportationto the disposal facility. In this regard, any necessary papers and/oridentifiers 32 for tracking the pharmaceutical waste 35 are attached toan outer surface of the container 20. Furthermore, any labels forshipping may also be attached to an outer surface of the container 20.

Once the sealed bag 17 containing the sealed pail 35 containing thetreated pharmaceutical waste 35 is positioned within the container 20,the container 20 is transported to the disposal facility, as shown byblock 114. In this regard, the pharmaceutical waste 35 has beensufficiently treated such that the pharmaceutical waste 35 is no longerclassified as a controlled substance. Thus, the waste 35 is renderedsafe and may be transported in compliance with all applicable laws.Furthermore, the waste 35 may be properly disposed of at the disposalfacility. Accordingly, contamination by the pharmaceutical waste 35 isavoided, federal laws are complied with, and the pharmaceutical waste 35is safely and properly destroyed.

Now, therefore,the following is claimed:
 1. A method for treatment anddisposal of pharmaceutical waste, comprising: placing pharmaceuticalwaste in a sealable pail; applying an acidic substance to thepharmaceutical waste in order to dissolve the pharmaceutical waste;stirring the acidic substance and the pharmaceutical waste until thepharmaceutical waste is dissolved; treating the pharmaceutical wastewith a denaturant; sealing the treated pharmaceutical waste within thesealable pail; sealing the sealable pail within a sealable bag; placingthe sealed bag within a container; and transporting the container to adisposal facility.
 2. The method of claim 1, wherein the acidicsubstance comprises a mineral acid.
 3. The method of claim 1, whereinthe denaturant comprises a quaternary ammonium cation.
 4. The method ofclaim 1, wherein the acidic substance is selected from a groupincluding: orthophosphoric acid, hydrochloric acid, acetic acid, nitricacid, sulfuric acid, polyphosphoric acid, boric acid, hydrofluoric acid,hydrobromic acid, and perchloric acid.
 5. The method of claim 4, whereinthe denaturant is selected from a group including: denatonium benzoate,denatonium saccharide, isopropanol, methyl ethyl ketone, methyl isobutylketone, pyridine, benzene, diethyl phthalate, and naptha.
 6. The methodof claim 1, wherein the stirring step comprises converting at least aportion of the pharmaceutical waste from a solid to a liquid.
 7. Amethod for treatment and disposal of pharmaceutical waste, comprising:dissolving pharmaceutical waste, whereby the dissolving comprisesapplying an acidic substance to the pharmaceutical waste; rendering thedissolved pharmaceutical waste inert, wherein the rendering comprisescombining the dissolved pharmaceutical waste with a denaturant; sealingthe dissolved pharmaceutical waste in a container; and transporting thecontainer.